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Managing advanced breast cancerManaging advanced breast cancer
NICE Pathways bring together everything NICE says on a topic in an interactiveflowchart. NICE Pathways are interactive and designed to be used online.
They are updated regularly as new NICE guidance is published. To view the latestversion of this NICE Pathway see:
http://pathways.nice.org.uk/pathways/advanced-breast-cancerNICE Pathway last updated: 07 May 2019
This document contains a single flowchart and uses numbering to link the boxes to theassociated recommendations.
Advanced breast cancerAdvanced breast cancer© NICE 2019. All rights reserved. Subject to Notice of rights.
Page 1 of 23
Managing advanced breast cancerManaging advanced breast cancer NICE Pathways
Advanced breast cancerAdvanced breast cancer© NICE 2019. All rights reserved. Subject to Notice of rights.
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1 Person with advanced (stage 4) breast cancer
No additional information
2 Hormone receptor-positive and HER2-positive disease
First-line treatment
Pertuzumab with trastuzumab and docetaxel
The following recommendation is from NICE technology appraisal guidance on pertuzumab with
trastuzumab and docetaxel for treating HER2-positive breast cancer.
Pertuzumab, in combination with trastuzumab and docetaxel, is recommended, within its
marketing authorisation, for treating HER2-positive metastatic or locally recurrent unresectable
breast cancer, in adults who have not had previous anti-HER2 therapy or chemotherapy for their
metastatic disease, only if the company provides pertuzumab within the agreed commercial
access arrangement.
See why we made the recommendation on pertuzumab with trastuzumab and docetaxel for
treating HER2-positive breast cancer [See page 18].
NICE has written information for the public on pertuzumab with trastuzumab and docetaxel.
Trastuzumab
The following recommendations are from NICE technology appraisal guidance on trastuzumab
for the treatment of advanced breast cancer.
Trastuzumab in combination with paclitaxel (combination trastuzumab is currently only licensed
for use with paclitaxel) is recommended as an option for people with tumours expressing HER2
scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer and in
whom anthracycline treatment is inappropriate.
Trastuzumab monotherapy is recommended as an option for people with tumours expressing
HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for
metastatic breast cancer. Prior chemotherapy must have included at least an anthracycline and
a taxane where these treatments are appropriate. It should also have included hormonal
Managing advanced breast cancerManaging advanced breast cancer NICE Pathways
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therapy in suitable oestrogen receptor positive patients.
HER2 levels should be scored using validated immunohistochemical techniques and in
accordance with published guidelines. Laboratories offering tissue sample immunocytochemical
or other predictive tests for therapy response should use validated standardised assay methods
and participate in and demonstrate satisfactory performance in a recognised external quality
assurance scheme.
NICE has written information for the public on trastuzumab.
Disease progression while receiving trastuzumab
For patients who are receiving treatment with trastuzumab for advanced breast cancer,
discontinue treatment with trastuzumab at the time of disease progression outside the central
nervous system. Do not discontinue trastuzumab if disease progression is within the central
nervous system alone.
Lapatinib or trastuzumab
The following recommendations are from NICE technology appraisal guidance on lapatinib or
trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic
hormone-receptor-positive breast cancer that overexpresses HER2.
Lapatinib in combination with an aromatase inhibitor is not recommended for first-line treatment
in postmenopausal women with metastatic hormone-receptor-positive breast cancer that
overexpresses HER2.
Trastuzumab in combination with an aromatase inhibitor is not recommended for first-line
treatment in postmenopausal women with metastatic hormone-receptor-positive breast cancer
that overexpresses HER2.
Postmenopausal women currently receiving lapatinib or trastuzumab in combination with an
aromatase inhibitor that is not recommended as above should have the option to continue
treatment until they and their clinicians consider it appropriate to stop.
NICE has written information for the public on lapatinib or trastuzumab in combination with an
aromatase inhibitor.
Managing advanced breast cancerManaging advanced breast cancer NICE Pathways
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Subcutaneous trastuzumab
NICE has published an evidence summary on early and metastatic HER2-positive breast
cancer: subcutaneous trastuzumab.
Second-line treatment
Trastuzumab emtansine
The following recommendations are from NICE technology appraisal guidance on trastuzumab
emtansine for treating HER2 positive advanced breast cancer after trastuzumab and a taxane.
Trastuzumab emtansine is recommended, within its marketing authorisation, as an option for
treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally
advanced or metastatic breast cancer in adults who previously received trastuzumab and a
taxane, separately or in combination. Patients should have either received prior therapy for
locally advanced or metastatic disease or developed disease recurrence during or within 6
months of completing adjuvant therapy. Trastuzumab emtansine is recommended only if the
company provides it with the discount agreed in the patient access scheme.
NICE has written information for the public on trastuzumab emtansine.
Third-line treatment
Eribulin for treating locally advanced or metastatic breast cancer after 2 or more
chemotherapy regimens
The following recommendations are from NICE technology appraisal guidance on erbulin for
treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens.
Eribulin is recommended as an option for treating locally advanced or metastatic breast cancer
in adults, only when:
it has progressed after at least 2 chemotherapy regimens (which may include ananthracycline or a taxane, and capecitabine)
the company provides eribulin with the discount agreed in the patient access scheme.
This guidance is not intended to affect the position of patients whose treatment with eribulin was
started within the NHS before this guidance was published. Treatment of those patients may
continue without change to whatever funding arrangements were in place for them before this
guidance was published until they and their NHS clinician consider it appropriate to stop.
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NICE has written information for the public on eribulin for treating locally advanced or metastatic
breast cancer after 2 or more chemotherapy regimens.
See what NICE says on medicines optimisation.
3 Hormone receptor-positive and HER2-negative disease
Endocrine therapy or chemotherapy
Offer endocrine therapy as first-line treatment for the majority of patients with ER-positive
advanced breast cancer.
Offer chemotherapy as first-line treatment for patients with ER-positive advanced breast cancer
whose disease is imminently life-threatening or requires early relief of symptoms because of
significant visceral organ involvement, providing they understand and are prepared to accept
the toxicity.
For patients with ER-positive advanced breast cancer who have been treated with
chemotherapy as their first-line treatment, offer endocrine therapy following the completion of
chemotherapy.
Endocrine therapy
Offer an aromatase inhibitor (either non-steroidal or steroidal) to:
postmenopausal women with ER-positive breast cancer and no prior history of endocrinetherapy
postmenopausal women with ER-positive breast cancer previously treated with tamoxifen.
Offer tamoxifen and ovarian suppression as first-line treatment to premenopausal and
perimenopausal women with ER-positive advanced breast cancer not previously treated with
tamoxifen.
Offer ovarian suppression to premenopausal and perimenopausal women who have previously
been treated with tamoxifen and then experience disease progression.
Offer tamoxifen as first-line treatment to men with ER-positive advanced breast cancer.
Aromatase inhibitors have been identified as a cause of secondary osteoporosis (see what
NICE says on osteoporosis).
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Chemotherapy
On disease progression, offer systemic sequential therapy to the majority of patients with
advanced breast cancer who have decided to be treated with chemotherapy.
Consider using combination chemotherapy to treat patients with advanced breast cancer for
whom a greater probability of response is important and who understand and are likely to
tolerate the additional toxicity.
For patients with advanced breast cancer who are not suitable for anthracyclines (because they
are contraindicated or because of prior anthracycline treatment either in the adjuvant or
metastatic setting), systemic chemotherapy should be offered in the following sequence:
first line: single-agent docetaxel
second line: single-agent vinorelbine or capecitabine
third line: single-agent capecitabine or vinorelbine (whichever was not used as second-linetreatment).
Other first-line treatment
Abemaciclib
The following recommendation is from NICE technology appraisal guidance on abemaciclib with
an aromatase inhibitor for previously untreated, hormone receptor -positive, HER2-negative,
locally advanced or metastatic breast cancer.
Abemaciclib with an aromatase inhibitor is recommended, within its marketing authorisation, as
an option for treating locally advanced or metastatic, hormone receptor-positive, human
epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based
therapy in adults. Abemaciclib is recommended only if the company provides it according to the
commercial arrangement.
See why we made the recommendations on abemaciclib.
NICE has written information for the public on abemaciclib.
Palbociclib
The following recommendation is from NICE technology appraisal guidance on palbociclib with
an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative,
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locally advanced or metastatic breast cancer.
Palbociclib, with an aromatase inhibitor, is recommended within its marketing authorisation, as
an option for treating hormone receptor-positive, human epidermal growth factor receptor
2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in
adults. Palbociclib is recommended only if the company provides it with the discount agreed in
the patient access scheme.
NICE has written information for the public on palbociclib.
Ribociclib
The following recommendation is from NICE technology appraisal guidance on ribociclib with an
aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally
advanced or metastatic breast cancer.
Ribociclib, with an aromatase inhibitor, is recommended within its marketing authorisation as an
option for treating hormone receptor-positive, human epidermal growth factor receptor
2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in
adults. Ribociclib is recommended only if the company provides it with the discount agreed in
the patient access scheme.
See why we made the recommendation on ribociclib [See page 19].
NICE has written information for the public on ribociclib.
Fulvestrant for untreated locally advanced or metastatic oestrogen-receptor positive
breast cancer
The following recommendation is from NICE technology appraisal guidance on fulvestrant for
untreated locally advanced or metastatic oestrogen-receptor positive breast cancer.
Fulvestrant is not recommended, within its marketing authorisation, for treating locally advanced
or metastatic oestrogen-receptor positive breast cancer in postmenopausal women who have
not had endocrine therapy before.
This recommendation is not intended to affect treatment with fulvestrant that was started in the
NHS before this guidance was published. People having treatment outside this recommendation
may continue without change to the funding arrangements in place for them before this
guidance was published, until they and their NHS clinician consider it appropriate to stop.
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See why we made the recommendation on fulvestrant for untreated locally advanced or
metastatic oestrogen-receptor positive breast cancer [See page 19].
NICE has written information for the public on fulvestrant for untreated locally advanced or
metastatic oestrogen-receptor positive breast cancer.
Second-line treatment
Abemaciclib with fulvestrant
The following recommendation is from NICE technology appraisal guidance on abemaciclib with
fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after
endocrine therapy.
Abemaciclib with fulvestrant is recommended for use within the Cancer Drugs Fund as an
option for treating hormone receptor-positive, human epidermal growth factor receptor 2
(HER2)-negative locally advanced or metastatic breast cancer in people who have had
endocrine therapy only if:
exemestane plus everolimus would be the most appropriate alternative and
the conditions in the managed access agreement for abemaciclib with fulvestrant arefollowed.
This recommendation is not intended to affect treatment with abemaciclib with fulvestrant that
was started in the NHS before this guidance was published. People having treatment outside
this recommendation may continue without change to the funding arrangements in place for
them before this guidance was published, until they and their NHS clinician consider it
appropriate to stop.
See why we made the recommendations on abemaciclib with fulvestrant.
NICE has written information for the public on abemaciclib with fulvestrant.
Everolimus
The following recommendation is from NICE technology appraisal guidance on everolimus with
exemestane for treating advanced breast cancer after endocrine therapy.
Everolimus, in combination with exemestane, is recommended within its marketing
authorisation, as an option for treating advanced HER2-negative, hormone-receptor-positive
breast cancer in postmenopausal women without symptomatic visceral disease that has
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recurred or progressed after a non-steroidal aromatase inhibitor. Everolimus is recommended
only if the company provides it with the discount agreed in the patient access scheme.
NICE has written information for the public on everolimus.
Fulvestrant for the treatment of locally advanced or metastatic breast cancer
The following recommendations are from NICE technology appraisal guidance on fulvestrant for
the treatment of locally advanced or metastatic breast cancer.
Fulvestrant is not recommended within its licensed indication, as an alternative to aromatase
inhibitors for the treatment of oestrogen-receptor-positive, locally advanced or metastatic breast
cancer in postmenopausal women whose cancer has relapsed on or after adjuvant anti-
oestrogen therapy, or who have disease progression on anti-oestrogen therapy.
Post-menopausal women currently receiving fulvestrant within its licensed indication as an
alternative to aromatase inhibitors for the treatment of oestrogen-receptor-positive, locally
advanced or metastatic breast cancer whose cancer has relapsed on or after adjuvant anti-
oestrogen therapy, or who have disease progression on anti-oestrogen therapy, should have the
option to continue treatment until they and their clinicians consider it appropriate to stop.
NICE has written information for the public on fulvestrant for the treatment of locally advanced
or metastatic breast cancer.
Eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy
regimen
The following recommendation is from NICE technology appraisal guidance on eribulin for
treating locally advanced or metastatic breast cancer after 1 chemotherapy regimen.
Eribulin is not recommended for treating locally advanced or metastatic breast cancer in adults
who have had only 1 chemotherapy regimen .
This guidance is not intended to affect treatment with eribulin that was started in the NHS before
this guidance was published. People having treatment outside this recommendation may
continue without change to the funding arrangements in place for them before this guidance
was published, until they and their NHS clinician consider it appropriate to stop.
See why we made the recommendation on eribulin for treating locally advanced or metastatic
breast cancer after 1 chemotherapy regimen [See page 18].
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NICE has written information for the public on eribulin for treating locally advanced or metastatic
breast cancer after 1 chemotherapy regimen.
Third-line treatment
Eribulin for treating locally advanced or metastatic breast cancer after 2 or more
chemotherapy regimens
The following recommendations are from NICE technology appraisal guidance on erbulin for
treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens.
Eribulin is recommended as an option for treating locally advanced or metastatic breast cancer
in adults, only when:
it has progressed after at least 2 chemotherapy regimens (which may include ananthracycline or a taxane, and capecitabine)
the company provides eribulin with the discount agreed in the patient access scheme.
This guidance is not intended to affect the position of patients whose treatment with eribulin was
started within the NHS before this guidance was published. Treatment of those patients may
continue without change to whatever funding arrangements were in place for them before this
guidance was published until they and their NHS clinician consider it appropriate to stop.
NICE has written information for the public on eribulin for treating locally advanced or metastatic
breast cancer after 2 or more chemotherapy regimens.
See what NICE says on medicines optimisation.
4 Hormone receptor-negative and HER2-positive disease
First-line treatment
Pertuzumab with trastuzumab and docetaxel
The following recommendation is from NICE technology appraisal guidance on pertuzumab with
trastuzumab and docetaxel for treating HER2-positive breast cancer.
Pertuzumab, in combination with trastuzumab and docetaxel, is recommended, within its
marketing authorisation, for treating HER2-positive metastatic or locally recurrent unresectable
breast cancer, in adults who have not had previous anti-HER2 therapy or chemotherapy for their
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metastatic disease, only if the company provides pertuzumab within the agreed commercial
access arrangement.
See why we made the recommendation on pertuzumab with trastuzumab and docetaxel for
treating HER2-positive breast cancer [See page 18].
NICE has written information for the public on pertuzumab with trastuzumab and docetaxel.
Trastuzumab
The following recommendations are from NICE technology appraisal guidance on trastuzumab
for the treatment of advanced breast cancer.
Trastuzumab in combination with paclitaxel (combination trastuzumab is currently only licensed
for use with paclitaxel) is recommended as an option for people with tumours expressing HER2
scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer and in
whom anthracycline treatment is inappropriate.
Trastuzumab monotherapy is recommended as an option for people with tumours expressing
HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for
metastatic breast cancer. Prior chemotherapy must have included at least an anthracycline and
a taxane where these treatments are appropriate. It should also have included hormonal
therapy in suitable oestrogen receptor positive patients.
HER2 levels should be scored using validated immunohistochemical techniques and in
accordance with published guidelines. Laboratories offering tissue sample immunocytochemical
or other predictive tests for therapy response should use validated standardised assay methods
and participate in and demonstrate satisfactory performance in a recognised external quality
assurance scheme.
NICE has written information for the public on trastuzumab.
Disease progression while receiving trastuzumab
For patients who are receiving treatment with trastuzumab for advanced breast cancer,
discontinue treatment with trastuzumab at the time of disease progression outside the central
nervous system. Do not discontinue trastuzumab if disease progression is within the central
nervous system alone.
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Subcutaneous trastuzumab
NICE has published an evidence summary on early and metastatic HER2-positive breast
cancer: subcutaneous trastuzumab.
Second-line treatment
Trastuzumab emtansine
The following recommendation is from NICE technology appraisal guidance on trastuzumab
emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane.
Trastuzumab emtansine is recommended, within its marketing authorisation, as an option for
treating HER2-positive, unresectable, locally advanced or metastatic breast cancer in adults
who previously received trastuzumab and a taxane, separately or in combination. Patients
should have either received prior therapy for locally advanced or metastatic disease or
developed disease recurrence during or within 6 months of completing adjuvant therapy.
Trastuzumab emtansine is recommended only if the company provides it with the discount
agreed in the patient access scheme.
NICE has written information for the public on trastuzumab emtansine.
Third-line treatment
Eribulin for treating locally advanced or metastatic breast cancer after 2 or more
chemotherapy regimens
The following recommendations are from NICE technology appraisal guidance on erbulin for
treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens.
Eribulin is recommended as an option for treating locally advanced or metastatic breast cancer
in adults, only when:
it has progressed after at least 2 chemotherapy regimens (which may include ananthracycline or a taxane, and capecitabine)
the company provides eribulin with the discount agreed in the patient access scheme.
This guidance is not intended to affect the position of patients whose treatment with eribulin was
started within the NHS before this guidance was published. Treatment of those patients may
continue without change to whatever funding arrangements were in place for them before this
guidance was published until they and their NHS clinician consider it appropriate to stop.
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NICE has written information for the public on eribulin for treating locally advanced or metastatic
breast cancer after 2 or more chemotherapy regimens.
See what NICE says on medicines optimisation.
5 Triple negative disease (hormone receptor-negative andHER2-negative)
Chemotherapy
On disease progression, offer systemic sequential therapy to the majority of patients with
advanced breast cancer who have decided to be treated with chemotherapy.
Consider using combination chemotherapy to treat patients with advanced breast cancer for
whom a greater probability of response is important and who understand and are likely to
tolerate the additional toxicity.
For patients with advanced breast cancer who are not suitable for anthracyclines (because they
are contraindicated or because of prior anthracycline treatment either in the adjuvant or
metastatic setting), systemic chemotherapy should be offered in the following sequence:
first line: single-agent docetaxel
second line: single-agent vinorelbine or capecitabine
third line: single-agent capecitabine or vinorelbine (whichever was not used as second-linetreatment).
Gemcitabine
The following recommendation is from NICE technology appraisal guidance on gemcitabine for
the treatment of metastatic breast cancer.
Gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an
option for the treatment of metastatic breast cancer only when docetaxel monotherapy or
docetaxel plus capecitabine are also considered appropriate.
NICE has written information for the public on gemcitabine.
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Other first-line treatments
Bevacizumab in combination with capecitabine
The following recommendations are from NICE technology appraisal on bevacizumab in
combination with capecitabine for the first-line treatment of metastatic breast cancer.
Bevacizumab in combination with capecitabine is not recommended within its marketing
authorisation for the first-line treatment of metastatic breast cancer, that is, when treatment with
other chemotherapy options including taxanes or anthracyclines is not considered appropriate,
or when taxanes or anthracyclines have been used as part of adjuvant treatment within the past
12 months.
People currently receiving bevacizumab in combination with capecitabine that is not
recommended according to above should have the option to continue treatment until they and
their clinician consider it appropriate to stop.
NICE has written information for the public on bevacizumab in combination with capecitabine.
Bevacizumab in combination with a taxane
The following recommendations are from NICE technology appraisal guidance on bevacizumab
in combination with a taxane for the first-line treatment of metastatic breast cancer.
Bevacizumab in combination with a taxane is not recommended for the first-line treatment of
metastatic breast cancer.
Patients currently receiving bevacizumab in combination with a taxane for the first-line treatment
of metastatic breast cancer should have the option to continue therapy until they and their
clinicians consider it appropriate to stop.
NICE has written information for the public on bevacizumab in combination with a taxane.
Other second-line treatment
Eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy
regimen
The following recommendation is from NICE technology appraisal guidance on eribulin for
treating locally advanced or metastatic breast cancer after 1 chemotherapy regimen.
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Eribulin is not recommended for treating locally advanced or metastatic breast cancer in adults
who have had only 1 chemotherapy regimen .
This guidance is not intended to affect treatment with eribulin that was started in the NHS before
this guidance was published. People having treatment outside this recommendation may
continue without change to the funding arrangements in place for them before this guidance
was published, until they and their NHS clinician consider it appropriate to stop.
See why we made the recommendation on eribulin for treating locally advanced or metastatic
breast cancer after 1 chemotherapy regimen [See page 18].
NICE has written information for the public on eribulin for treating locally advanced or metastatic
breast cancer after 1 chemotherapy regimen.
Other third-line treatment
Eribulin for treating locally advanced or metastatic breast cancer after 2 or more
chemotherapy regimens
The following recommendations are from NICE technology appraisal guidance on erbulin for
treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens.
Eribulin is recommended as an option for treating locally advanced or metastatic breast cancer
in adults, only when:
it has progressed after at least 2 chemotherapy regimens (which may include ananthracycline or a taxane, and capecitabine)
the company provides eribulin with the discount agreed in the patient access scheme.
This guidance is not intended to affect the position of patients whose treatment with eribulin was
started within the NHS before this guidance was published. Treatment of those patients may
continue without change to whatever funding arrangements were in place for them before this
guidance was published until they and their NHS clinician consider it appropriate to stop.
NICE has written information for the public on eribulin for treating locally advanced or metastatic
breast cancer after 2 or more chemotherapy regimens.
See what NICE says on medicines optimisation.
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6 Managing complications
See Advanced breast cancer / Advanced breast cancer: managing complications
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Eribulin for treating locally advanced or metastatic breast cancer after 1chemotherapy regimen
People with advanced breast cancer who have had 1 chemotherapy regimen are usually then
offered an anthracycline, a taxane or capecitabine, depending on what they have had already.
The clinical trial results for eribulin showed that it did not increase progression-free survival, but
there was an average overall survival increase of 4.6 months compared with capecitabine.
Since treatment is changed when the disease progresses, and eribulin would have been
stopped at that stage, it is not clear whether the increase in overall survival is because of
eribulin, or related to the treatments given after eribulin. Eribulin is already recommended after
2 previous chemotherapy treatments, and there are no trials which compare its effectiveness
given after 1 or 2 previous treatments, so this remains uncertain.
Eribulin meets NICE's criteria to be considered a life-extending treatment at the end of life. The
estimates of cost effectiveness for eribulin range from £36,200 to £82,700 per quality-adjusted
life year (QALY) gained. The most plausible estimate of cost effectiveness, based on a revised
company model and the committee's preferred assumptions, is £69,800 per QALY gained. This
is above what NICE normally considers to be acceptable for end-of-life treatments. Therefore,
eribulin cannot be recommended as a cost-effective option for locally advanced or metastatic
breast cancer in adults who have had only 1 chemotherapy regimen.
For more information see the committee discussion in the NICE technology appraisal guidance
on eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy
regimen.
Pertuzumab with trastuzumab and docetaxel for treating HER2-positivebreast cancer
This recommendation is for a drug that has been available on the Cancer Drugs Fund for
several years and the committee recognised this as an exceptional circumstance. In this
context, the committee considered it reasonable to apply flexibility in its interpretation of the
criteria for special consideration as a life-extending treatment for people with a short life
expectancy, but noted that the weight applied to the quality-adjusted life years gained would not
be at the maximum allocated in other, more regular, circumstances where the end of life criteria
have been applied. With this in mind, the committee accepted that the incremental cost-
effectiveness ratio, taking into account the commercial access arrangement, provides for an
acceptable use of NHS resources.
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For more information see the committee discussion in the NICE technology appraisal guidance
on pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer.
Ribociclib
Clinical trial evidence shows that ribociclib plus letrozole improves progression-free survival
compared with letrozole alone. Although we do not know yet if improvement leads to a survival
benefit with ribociclib. But with the patient access scheme discount, ribociclib is a cost-effective
use of NHS resources and it can be recommended.
For more information see the committee discussion in the NICE technology appraisal guidance
on ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive,
HER2-negative, locally advanced or metastatic breast cancer.
Fulvestrant for untreated locally advanced or metastatic oestrogen-receptorpositive breast cancer
People with untreated disease are first offered an aromatase inhibitor, either anastrozole or
letrozole. These drugs are considered to be similarly effective. Tamoxifen is used for women in
whom an aromatase inhibitor is not tolerated or is contraindicated. Fulvestrant is a further
treatment option that may have additional benefits for some women. However, the final results
on overall survival from the FALCON trial are not available yet, so it is unclear whether
fulvestrant will extend overall survival compared with aromatase inhibitors.
Because of the uncertainty in the clinical evidence, the cost effectiveness of fulvestrant
compared with existing treatments is highly uncertain. However it is likely to be above the range
normally considered a cost-effective use of NHS resources, so fulvestrant cannot be
recommended.
For more information see the committee discussion in the NICE technology appraisal guidance
on fulvestrant for untreated locally advanced or metastatic oestrogen-receptor positive breast
cancer.
Glossary
ER
(oestrogen receptor)
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HER2
(human epidermal growth factor receptor 2)
PET-CT
(positron emission tomography fused with computed tomography)
Sources
Advanced breast cancer: diagnosis and treatment (2009 updated 2017) NICE guideline CG81
Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced
breast cancer after endocrine therapy (2019) NICE technology appraisal guidance 579
Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive,
HER2-negative, locally advanced or metastatic breast cancer (2019) NICE technology appraisal
guidance 563
Eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy regimen
(2018) NICE technology appraisal guidance 515
Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer (2018)
NICE technology appraisal guidance 509
Fulvestrant for untreated locally advanced or metastatic oestrogen-receptor positive breast
cancer (2018) NICE technology appraisal guidance 503
Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive,
HER2-negative, locally advanced or metastatic breast cancer (2017) NICE technology appraisal
guidance 496
Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive,
HER2-negative, locally advanced or metastatic breast cancer (2017) NICE technology appraisal
guidance 495
Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab
and a taxane (2017) NICE technology appraisal guidance 458
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Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy
regimens (2016) NICE technology appraisal guidance 423
Everolimus with exemestane for treating advanced breast cancer after endocrine therapy (2016)
NICE technology appraisal guidance 421
Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast
cancer (2012) NICE technology appraisal guidance 263
Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of
metastatic hormone-receptor-positive breast cancer that overexpresses HER2 (2012) NICE
technology appraisal guidance 257
Fulvestrant for the treatment of locally advanced or metastatic breast cancer (2011) NICE
technology appraisal guidance 239
Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast
cancer (2011) NICE technology appraisal guidance 214
Gemcitabine for the treatment of metastatic breast cancer (2007) NICE technology appraisal
guidance 116
Guidance on the use of trastuzumab for the treatment of advanced breast cancer (2002) NICE
technology appraisal guidance 34
Your responsibility
Guidelines
The recommendations in this guideline represent the view of NICE, arrived at after careful
consideration of the evidence available. When exercising their judgement, professionals and
practitioners are expected to take this guideline fully into account, alongside the individual
needs, preferences and values of their patients or the people using their service. It is not
mandatory to apply the recommendations, and the guideline does not override the responsibility
to make decisions appropriate to the circumstances of the individual, in consultation with them
and their families and carers or guardian.
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Local commissioners and providers of healthcare have a responsibility to enable the guideline
to be applied when individual professionals and people using services wish to use it. They
should do so in the context of local and national priorities for funding and developing services,
and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to
advance equality of opportunity and to reduce health inequalities. Nothing in this guideline
should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable
health and care system and should assess and reduce the environmental impact of
implementing NICE recommendations wherever possible.
Technology appraisals
The recommendations in this interactive flowchart represent the view of NICE, arrived at after
careful consideration of the evidence available. When exercising their judgement, health
professionals are expected to take these recommendations fully into account, alongside the
individual needs, preferences and values of their patients. The application of the
recommendations in this interactive flowchart is at the discretion of health professionals and
their individual patients and do not override the responsibility of healthcare professionals to
make decisions appropriate to the circumstances of the individual patient, in consultation with
the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable
the recommendations to be applied when individual health professionals and their patients wish
to use it, in accordance with the NHS Constitution. They should do so in light of their duties to
have due regard to the need to eliminate unlawful discrimination, to advance equality of
opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable
health and care system and should assess and reduce the environmental impact of
implementing NICE recommendations wherever possible.
Medical technologies guidance, diagnostics guidance and interventional proceduresguidance
The recommendations in this interactive flowchart represent the view of NICE, arrived at after
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careful consideration of the evidence available. When exercising their judgement, healthcare
professionals are expected to take these recommendations fully into account. However, the
interactive flowchart does not override the individual responsibility of healthcare professionals to
make decisions appropriate to the circumstances of the individual patient, in consultation with
the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in
their local context, in light of their duties to have due regard to the need to eliminate unlawful
discrimination, advance equality of opportunity, and foster good relations. Nothing in this
interactive flowchart should be interpreted in a way that would be inconsistent with compliance
with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable
health and care system and should assess and reduce the environmental impact of
implementing NICE recommendations wherever possible.
Managing advanced breast cancerManaging advanced breast cancer NICE Pathways
Advanced breast cancerAdvanced breast cancer© NICE 2019. All rights reserved. Subject to Notice of rights.
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